Acella Pharmaceuticals, LLC
Form 483 issued January 7, 2020 · Alpharetta, Georgia
- Inspection
- Jan 6 – Jan 7, 2020
- Investigators
- Cayie Gicleon· Veronica Fuentes
- Observations
- 3
- Pages
- 3
- FEI number
- 3006691461
In short: On January 7, 2020, FDA issued a Form 483 with 3 observations to Acella Pharmaceuticals, LLC in Alpharetta, Georgia (FEI 3006691461) after an inspection that ran Jan 6 – Jan 7, 2020. The investigators were Cayie Gicleon and Veronica Fuentes. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
3 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (2×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
Complaint procedures are deficient in that they do not include provisions that allow for the review…
- 03
Written complaint records do not include, where…
This inspection in context
Cayie Gicleon
1 document · 2020
Cites 211.198 (complaint files) more than any other section. Most of their documents are for sites in Georgia.
The firmAcella Pharmaceuticals, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acella Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Acella Pharmaceuticals, LLC?
Cayie Gicleon and Veronica Fuentes are named on this Form 483, for the inspection of Jan 6 – Jan 7, 2020. Each investigator has a profile showing what they cite most.
When was Acella Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jan 6 – Jan 7, 2020, and the Form 483 is dated January 7, 2020.
How do I get the full Form 483 for Acella Pharmaceuticals, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.